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FDA 510(k) Applications Submitted by Medtecs (Taiwan) Corp.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K210414
02/11/2021
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
Medtecs (Taiwan) Corp.
K203376
11/17/2020
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G
Medtecs (Taiwan) Corp.
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